ConstipationPhase 4NCT02789111

Trial of Alvimopan in Major Spine Surgery

A Phase 4 study testing Alvimopan in people with Constipation, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Constipation
What is being tested?: Alvimopan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 49 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2016to 1 Dec 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Major spine surgery scheduled as part of clinical care
18-80 years

Who cannot join

More than three doses of any opioid within one week of surgery
Pregnancy
Prisoners
Unable to provide consent
Emergency surgery
Chronic kidney disease stage 5 (GFR < 15 ml/min)
Severe hepatic impairment
Recent myocardial infarction (within the last 3 months)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Virginia
Charlottesville, Virginia, 22908

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled Trial of Alvimopan in Major Spine Surgery

The Investigator has chosen to study the reconstructive spinal surgery patient population because it is believed that the use of alvimopan in these patients at the University of Virginia will give the scientific community significant insight into the broader applicability of this drug into other surgical populations, the impact of this drug on the perception of pain (as opposed to simply the consumption of opioids), and its impact on total hospital charges, resource utilization, and functional outcomes.

Read the detailed description

Pain control following major spine surgery is difficult to achieve. Opiates are often necessary in high doses, and may be associated with significant side effects. Such side effects may include urinary retention, altered mental status, depressed respiratory drive, and constipation, and may lead to reduced nutritional intake in the postoperative period. Importantly, post-operative nutrition may impact the incidence of complications following spine surgery.1 Alvimopan is a peripheral-acting opiate antagonist designed to decrease the gastrointestinal complications of perioperative systemic opioid administration.

Pain control following major spine surgery is difficult to achieve. Opiates are often necessary in high doses, and may be associated with significant side effects including constipation. Alvimopan is a drug approved by the Food and Drug Administration (FDA) and is used to help the bowel recover more quickly in patients who are having bowel surgery, so that they can eat solid foods and have regular bowel movements. Alvimopan is in a class of medications called peripherally acting mu-opioid receptor antagonists. It works by protecting the bowel from the constipation effects of opioid (narcotic) medications that are used to treat pain after surgery.

The purpose of this study is to determine if the use of alvimopan in major spine surgery reduces the time to first bowel movement. By assessing the use of alvimopan in reconstructive spinal surgery patients, researchers hope to give the scientific community insight into the broader use of this drug in other surgical populations, as well as gathering information on the impact of hospital charges and overall post-operative patient satisfaction.

Conditions: Constipation
Being tested: Alvimopan, Placebo
Medical subject headings: Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlvimopanDrug
Also called Entereg
Alviimopan 12 mg twice daily up to 15 doses
PlaceboDrug
Placebo twice daily up to 15 doses

Study groups in NCT02789111
Study group	Role	What they receive
Alvimopan	Active comparator	12 mg alvimopan twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses. Receives: Drug: Alvimopan
Placebo	Placebo comparator	Placebo twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to First Bowel Movement
time to first bowel movement after surgery
Measured: Time to event( up to 7 days); From date of day of surgery until the date of first documented bowel movement

Secondary outcomes (1)

Time to Resumption of PO Intake
time to resumption oral intake after surgery
Measured: time to event ( up to 7 days); From date of day of surgery until the date of first documented PO intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20161 Dec 2018

First posted2 Jun 2016 (estimated)
Study start1 Jun 2016
Primary completion1 Dec 2018
Study completion1 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for ConstipationStudies of the same condition, open and under way.
More trials run by University of VirginiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02789111
Sponsor's protocol ID: 18781
Status last verified: Nov 2020
First submitted: 10 May 2016
Last updated: 1 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Stambough JL, Beringer D. Postoperative wound infections complicating adult spine surgery. J Spinal Disord. 1992 Sep;5(3):277-85. doi: 10.1097/00002517-199209000-00005.
PubMed 1520986
Crawford MW, Hickey C, Zaarour C, Howard A, Naser B. Development of acute opioid tolerance during infusion of remifentanil for pediatric scoliosis surgery. Anesth Analg. 2006 Jun;102(6):1662-7. doi: 10.1213/01.ane.0000216036.95705.c2.
PubMed 16717305
Guignard B, Bossard AE, Coste C, Sessler DI, Lebrault C, Alfonsi P, Fletcher D, Chauvin M. Acute opioid tolerance: intraoperative remifentanil increases postoperative pain and morphine requirement. Anesthesiology. 2000 Aug;93(2):409-17. doi: 10.1097/00000542-200008000-00019.
PubMed 10910490
Rauf K, Vohra A, Fernandez-Jimenez P, O'Keeffe N, Forrest M. Remifentanil infusion in association with fentanyl-propofol anaesthesia in patients undergoing cardiac surgery: effects on morphine requirement and postoperative analgesia. Br J Anaesth. 2005 Nov;95(5):611-5. doi: 10.1093/bja/aei237. Epub 2005 Sep 9.
PubMed 16155034
Cortinez LI, Brandes V, Munoz HR, Guerrero ME, Mur M. No clinical evidence of acute opioid tolerance after remifentanil-based anaesthesia. Br J Anaesth. 2001 Dec;87(6):866-9. doi: 10.1093/bja/87.6.866.
PubMed 11878688
Fletcher D, Pinaud M, Scherpereel P, Clyti N, Chauvin M. The efficacy of intravenous 0.15 versus 0.25 mg/kg intraoperative morphine for immediate postoperative analgesia after remifentanil-based anesthesia for major surgery. Anesth Analg. 2000 Mar;90(3):666-71. doi: 10.1097/00000539-200003000-00029.
PubMed 10702454
Lee LH, Irwin MG, Lui SK. Intraoperative remifentanil infusion does not increase postoperative opioid consumption compared with 70% nitrous oxide. Anesthesiology. 2005 Feb;102(2):398-402. doi: 10.1097/00000542-200502000-00024.
PubMed 15681957
Bell TJ, Poston SA, Kraft MD, Senagore AJ, Delaney CP, Techner L. Economic analysis of alvimopan in North American Phase III efficacy trials. Am J Health Syst Pharm. 2009 Aug 1;66(15):1362-8. doi: 10.2146/ajhp080329.
PubMed 19635772
Delaney CP, Weese JL, Hyman NH, Bauer J, Techner L, Gabriel K, Du W, Schmidt WK, Wallin BA; Alvimopan Postoperative Ileus Study Group. Phase III trial of alvimopan, a novel, peripherally acting, mu opioid antagonist, for postoperative ileus after major abdominal surgery. Dis Colon Rectum. 2005 Jun;48(6):1114-25; discussion 1125-6; author reply 1127-9. doi: 10.1007/s10350-005-0035-7.
PubMed 15906123
Ludwig K, Enker WE, Delaney CP, Wolff BG, Du W, Fort JG, Cherubini M, Cucinotta J, Techner L. Gastrointestinal tract recovery in patients undergoing bowel resection: results of a randomized trial of alvimopan and placebo with a standardized accelerated postoperative care pathway. Arch Surg. 2008 Nov;143(11):1098-105. doi: 10.1001/archsurg.143.11.1098.
PubMed 19015469
Viscusi ER, Goldstein S, Witkowski T, Andonakakis A, Jan R, Gabriel K, Du W, Techner L, Wallin B. Alvimopan, a peripherally acting mu-opioid receptor antagonist, compared with placebo in postoperative ileus after major abdominal surgery: results of a randomized, double-blind, controlled study. Surg Endosc. 2006 Jan;20(1):64-70. doi: 10.1007/s00464-005-0104-y. Epub 2005 Dec 7.
PubMed 16333556
Wolff BG, Michelassi F, Gerkin TM, Techner L, Gabriel K, Du W, Wallin BA; Alvimopan Postoperative Ileus Study Group. Alvimopan, a novel, peripherally acting mu opioid antagonist: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial of major abdominal surgery and postoperative ileus. Ann Surg. 2004 Oct;240(4):728-34; discussion 734-5. doi: 10.1097/01.sla.0000141158.27977.66.
PubMed 15383800
Herzog TJ, Coleman RL, Guerrieri JP Jr, Gabriel K, Du W, Techner L, Fort JG, Wallin B. A double-blind, randomized, placebo-controlled phase III study of the safety of alvimopan in patients who undergo simple total abdominal hysterectomy. Am J Obstet Gynecol. 2006 Aug;195(2):445-53. doi: 10.1016/j.ajog.2006.01.039. Epub 2006 Apr 19.
PubMed 16626607

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

All Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blind, Placebo-Controlled Trial of Alvimopan in Major Spine Surgery
ClinicalTrials.gov ID: NCT02789111
Acronym / sponsor ID: 18781
Conditions: Constipation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: 1 Jun 2016 (actual)
Primary completion: 1 Dec 2018 (actual)
Study completion: 1 Dec 2018 (actual)
First posted: 2 Jun 2016 (estimated)
Results: Posted 1 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Alvimopan	Active comparator	Drug: Alvimopan12 mg alvimopan twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.
Placebo	Placebo comparator	Drug: PlaceboPlacebo twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Major spine surgery scheduled as part of clinical care
18-80 years

Key exclusion criteria (8 listed)

More than three doses of any opioid within one week of surgery
Pregnancy
Prisoners
Unable to provide consent
Emergency surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AlvimopanAlso: EnteregAlviimopan 12 mg twice daily up to 15 doses	Drug	Alvimopan
PlaceboPlacebo twice daily up to 15 doses	Drug	Placebo

Primary outcome

Time to First Bowel Movement
Time frame: Time to event( up to 7 days); From date of day of surgery until the date of first documented bowel movement
time to first bowel movement after surgery

1 secondary outcome

Time to Resumption of PO Intake
Time frame: time to event ( up to 7 days); From date of day of surgery until the date of first documented PO intake

Results and safety

Results posted to the registry on 1 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alvimopan	24	23
Placebo	25	21

Primary outcome: Time to First Bowel Movement

Time frame: Time to event( up to 7 days); From date of day of surgery until the date of first documented bowel movement. Mean (Full Range). Unit: hours

Measure	Alvimopan n = 23	Placebo n = 20
Value	50 (22 to 80)	64 (40 to 114)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from the date of surgery until 6 weeks after hospital discharge.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alvimopan	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Placebo	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 1520986Stambough JL, Beringer D. Postoperative wound infections complicating adult spine surgery. J Spinal Disord. 1992 Sep;5(3):277-85. doi: 10.1097/00002517-199209000-00005.
Background: PubMed 16717305Crawford MW, Hickey C, Zaarour C, Howard A, Naser B. Development of acute opioid tolerance during infusion of remifentanil for pediatric scoliosis surgery. Anesth Analg. 2006 Jun;102(6):1662-7. doi: 10.1213/01.ane.0000216036.95705.c2.
Background: PubMed 10910490Guignard B, Bossard AE, Coste C, Sessler DI, Lebrault C, Alfonsi P, Fletcher D, Chauvin M. Acute opioid tolerance: intraoperative remifentanil increases postoperative pain and morphine requirement. Anesthesiology. 2000 Aug;93(2):409-17. doi: 10.1097/00000542-200008000-00019.
Background: PubMed 16155034Rauf K, Vohra A, Fernandez-Jimenez P, O'Keeffe N, Forrest M. Remifentanil infusion in association with fentanyl-propofol anaesthesia in patients undergoing cardiac surgery: effects on morphine requirement and postoperative analgesia. Br J Anaesth. 2005 Nov;95(5):611-5. doi: 10.1093/bja/aei237. Epub 2005 Sep 9.
Background: PubMed 11878688Cortinez LI, Brandes V, Munoz HR, Guerrero ME, Mur M. No clinical evidence of acute opioid tolerance after remifentanil-based anaesthesia. Br J Anaesth. 2001 Dec;87(6):866-9. doi: 10.1093/bja/87.6.866.
Background: PubMed 10702454Fletcher D, Pinaud M, Scherpereel P, Clyti N, Chauvin M. The efficacy of intravenous 0.15 versus 0.25 mg/kg intraoperative morphine for immediate postoperative analgesia after remifentanil-based anesthesia for major surgery. Anesth Analg. 2000 Mar;90(3):666-71. doi: 10.1097/00000539-200003000-00029.
Background: PubMed 15681957Lee LH, Irwin MG, Lui SK. Intraoperative remifentanil infusion does not increase postoperative opioid consumption compared with 70% nitrous oxide. Anesthesiology. 2005 Feb;102(2):398-402. doi: 10.1097/00000542-200502000-00024.
Background: PubMed 19635772Bell TJ, Poston SA, Kraft MD, Senagore AJ, Delaney CP, Techner L. Economic analysis of alvimopan in North American Phase III efficacy trials. Am J Health Syst Pharm. 2009 Aug 1;66(15):1362-8. doi: 10.2146/ajhp080329.
Background: PubMed 15906123Delaney CP, Weese JL, Hyman NH, Bauer J, Techner L, Gabriel K, Du W, Schmidt WK, Wallin BA; Alvimopan Postoperative Ileus Study Group. Phase III trial of alvimopan, a novel, peripherally acting, mu opioid antagonist, for postoperative ileus after major abdominal surgery. Dis Colon Rectum. 2005 Jun;48(6):1114-25; discussion 1125-6; author reply 1127-9. doi: 10.1007/s10350-005-0035-7.
Background: PubMed 19015469Ludwig K, Enker WE, Delaney CP, Wolff BG, Du W, Fort JG, Cherubini M, Cucinotta J, Techner L. Gastrointestinal tract recovery in patients undergoing bowel resection: results of a randomized trial of alvimopan and placebo with a standardized accelerated postoperative care pathway. Arch Surg. 2008 Nov;143(11):1098-105. doi: 10.1001/archsurg.143.11.1098.
Background: PubMed 16333556Viscusi ER, Goldstein S, Witkowski T, Andonakakis A, Jan R, Gabriel K, Du W, Techner L, Wallin B. Alvimopan, a peripherally acting mu-opioid receptor antagonist, compared with placebo in postoperative ileus after major abdominal surgery: results of a randomized, double-blind, controlled study. Surg Endosc. 2006 Jan;20(1):64-70. doi: 10.1007/s00464-005-0104-y. Epub 2005 Dec 7.
Background: PubMed 15383800Wolff BG, Michelassi F, Gerkin TM, Techner L, Gabriel K, Du W, Wallin BA; Alvimopan Postoperative Ileus Study Group. Alvimopan, a novel, peripherally acting mu opioid antagonist: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial of major abdominal surgery and postoperative ileus. Ann Surg. 2004 Oct;240(4):728-34; discussion 734-5. doi: 10.1097/01.sla.0000141158.27977.66.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bhiken Naik, MBBCh principal investigator

Anesthesiology Attending

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Alvimopan in people with Constipation, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Bowel Movement (time frame: Time to event( up to 7 days); From date of day of surgery until the date of first documented bowel movement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02789111, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.